To compare the effects of conventional cytology testing with concommitant HPV-cytology testing for the detection of high grade cervical lesions in primary cervical cancer screening in Hong Kong

Hypotheses:

There is a significant difference in the number of CIN2+ cases detected between the cytology testing group and the cytology-HPV co-testing group at baseline.

Significantly more CIN2+ cases will be detected at the second round of screening among participants with normal cytology result in the control arm than those with normal cytology and negative HPV results in the intervention arm.

Subjects in the control arm will receive conventional cytology testing and HPV testing at baseline. Follow up management will be based on the cytology result according to current practice.

Experimental: HPV-cytology

Subjects in the HPV-cytology arm will receive HPV testing and cytology testing at baseline. Follow up management will be based on both results.

Procedure: HPV-cytology co-testing

Subjects will receive HPV testing and conventional cytology testing at baseline. Follow up management will be based on both results.

Eligibility

Ages Eligible for Study:

30 Years to 60 Years

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Ethnic Chinese women aged 30 to 60 years who have completed a written consent

Women who have not attended screening for the past 3 years or more will be given priority

Exclusion Criteria:

Currently pregnant

Without a cervix

Congenital abnormalities of the lower genital tract

Previous history of invasive cervical cancer

Who has been followed-up or treated for an abnormal cytology result in the past 12 months

Who are unable to provide consent

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01058460